Ultrasound Guided Regional Anesthesia for Acute Injury in Low Resource Settings

Pain Management Clinical Trial

Official title:

Feasibility, Perceived Utility and Sustainability of Using Ultrasound-guided Regional Anesthesia by Local Providers in a Limited Resource Conflict Setting

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02084225
• Other study ID #: NB0001
• Status: Active, not recruiting
• Phase: N/A
• First received: March 9, 2014
• Last updated: March 19, 2014
• Start date: January 2012
• Est. completion date: October 2014

Study information

• Verified date: March 2014
• Source: Salmon, Margaret, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Congo, Democratic Republic of the: Ministry of HealthEthiopia: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine feasibility, perceived utility and sustainability of training local providers in ultrasound guided regional anesthesia for acute pain management in a limited-resource conflict setting.

Description:

To the investigators knowledge, this is the first study of feasibility, perceived utility and sustainability of USRA as a pain management tool in a low-resource conflict setting and is one of the only large studies to date to assess USRA by local providers for emergent pain relief due to injury in patients presenting to an acute care center.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• participants were chosen by hospital administration

Exclusion Criteria:

• only chosen participants were included

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Injuries
• Pain Management

Intervention

Procedure:
• ultrasound guided regional nerve block
participants were the physicians performing the procedure

Locations

Country	Name	City	State
Congo	HEAL Hospital	Goma
Congo	John Maurice Kikuni Salmu	Kindu
Ethiopia	Black Lion Hospital	Addis Ababa

Sponsors (7)

Lead Sponsor	Collaborator
Salmon, Margaret, M.D.	company had no role in the study., had no other role in the study., MedShare - (in kind), Sonosite/Fuji Film - (in kind), The needles and syringes and kit contents were given to the sites by MedShare but the, The ultrasound for the study was given to the sites by Sonosite/Fuji but the company

Countries where clinical trial is conducted

Congo,  Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient pain reduction (VAS)	Pain reduction was calculated using 1 - 10 of a VAS. The patients was asked to rate pain before and 20 minutes after the procedure	up to 18 months	No
Other	Post procedure serious and non serious adverse event	Patients were followed up to 48 hours post procedure in order to monitor for adverse events including residual nerve sensory deficit and/or infection at the injection site	before and up to 48 hours after every block performed	Yes
Other	Indication for use of USRA by participant	Participants recorded patient indication for offering USRA when presenting with acute injury including burns gun shot wounds lacerations, bone injuries soft tissue injuries and painful dressing changes	up to 18 months of study period	No
Primary	Participant perceived utility of ultrasound guided nerve block	Participants filled out a data sheet on each block performed. The participant stated yes/no if a block was found to have positive utility	study start - ongoing (24 months)	No
Secondary	Participant course satisfaction	Post course evaluation of course satisfaction and balance of didactic simulation and clinical scanning	at course end (5 days)	No